The latest from DTC Perspectives

A Powerful and Independent FDA

The Wall Street Journal reported on 7/30 that there is growing sentiment in Congress to drastically reform the FDA so it has fewer ties with the industries it regulates. There are many in Congress who feel the FDA has done a poor job protecting the public and is too close to the drug and food industry.

John Dingell is quoted as saying, “There's a total inability of the FDA to carry out its mission.” The WSJ story by Alicia Mundy says “leading Democrats would like to see less Madison Avenue-style television commercials for prescription drugs.” It is not only leading Democrats unhappy with FDA. Senator Grassley, a Republican, has been leading the charge saying the FDA is too cozy with companies they regulate. Of course DTC is only causing a small part of the anger in Congress towards the FDA. Congress is concerned with food supply safety, drug recalls, FDA ability and willingness to impose penalties, and speed of response to crises, among many others.

Alicia Mundy says, “2009 may bring the most significant overhaul at the FDA in a generation.” Should DTC advertisers and all those whose livelihoods depend on the existence of mass DTC advertising be worried? My view is a modified yes. No one is talking seriously about banning DTC ads. The key issues are over a longer moratorium on new products and FDA pre-approval of ads. The advertising industry is opposed to both, fearing a slippery slope of added regulation leading to perhaps a full ban.

Many leading drug makers have already endorsed a 6 month moratorium, and the issue is the additional 18-30 months wanted by many in Congress. Most television ads are pre-reviewed by DDMAC on a voluntary basis, so making it mandatory is not as drastic a practical change as it seems. I do think a Democratic administration and Congress will press the industry for more than 6 months and probably get an additional time commitment to hold off ads for new products. The industry has to appear willing to negotiate because I doubt Congress will accept the 6 month number. My guess is that 12 months will be the negotiated time frame.

A more legislatively empowered and staffed FDA can make it harder to do DTC as we know it, even without changing the moratorium time frame or requiring pre-approval. They can just find more things that they say are violative and reject more ads. How can they do this? They can cite distracting visuals when risk is discussed or cite claims that are not fairly balanced. I never thought DDMAC was easy to get claims through when I worked with them in the 1990s. So a new tougher policy may add significant delays and uncertainty to fielding television ads.

Of course a tougher FDA may not make all DTC marketers upset. Those marketers and suppliers in the Internet area and point of care environments may benefit from more restrictions on broadcast ads. Also, print ads may become easier to execute than television if more risk explanation is required. I am highly confident the FDA is not going to return to pre-1997 days and legislate television out. It just may be harder to do 30 and 60 second ads.

Individual drug companies should act carefully when constructing their broadcast ads. Any ad that sounds like a shampoo commercial is likely to get Congressional attention. I would keep my ads sober, informative and shy away from comedy, celebrities and cutting edge creative techniques. That may make the agency's creative job “less fun,” but industry image is critical over the next year. I also expect the new FDA to do more studies on what consumers perceive ads to say versus what they actually say. Some ads may comply with the approved labeling, but consumer interpretation may extend those claims into an unapproved area. Although more Congressional action on drug regulation has been threatened for years, I sense 2009 may be the year something really happens.